Unfortunately, there are many misconceptions about the regulation of cosmetics in the United States. Here are some I hear time and again:
- “The FDA doesn’t regulate cosmetics.”
- “Skincare manufacturers can do whatever they want regarding ingredients in our creams and lotions.”
- “Beware! Beauty products are untested and unregulated.”
These statements are all false. Let me say it again, they are false, false, and false. The fact is the U.S. Food and Drug Administration (FDA) regulates the cosmetics industry under the broad regulatory authority of the Food, Drug, and Cosmetic Act to ensure the safety of cosmetic products.
FDA Cosmetic Regulation vs. Approval
The Food, Drug, and Cosmetic Act was first passed by Congress in 1938 and amended many times since. It prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. The FDA, however, does not approve cosmetics in the same way that they approve drugs. This is why is the confusion occurs.
It is the responsibility of the manufacturer to ensure that their cosmetic product is safe when used under customary conditions. They must also be sure that the product is appropriately labeled.
There are no FDA required tests for cosmetic products or ingredients. Basically, if a company or individual manufacturers or markets cosmetics, they have a legal obligation to make sure the product is safe and correctly labeled.
The FDA’s definition of a cosmetic
The FDA defines a cosmetic as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]
By law, cosmetics cannot intend to actually change the structure or function of the skin. Nor can they be intended to treat or prevent skin disease. They may, however, claim to cleanse the body, beautify or adorn.
This is why you often see ads that say that a product “Decreases the appearance of fine lines” rather than “Rids the skin of fine lines.” Examples of cosmetics include makeup, moisturizers, perfumes, and nail polish.
When a cosmetic company violates the law by making a drug claim about their products without adhering to the requirements for drugs and getting a required pre-market approval, the FDA may issue a warning letter and recommend corrective action.
What is an adulterated cosmetic?
As I mentioned, the FDA prohibits the marketing of adulterated cosmetics. According to the Food, Drug, and Cosmetics Act, an adulterated product has one or more of the following features:
- It contains a poisonous or harmful ingredient that may harm users when the product is used as described on the product label.
- Or, it contains a “filthy, putrid, or decomposed substance.”
- It is packaged, prepared or manufactured in unsanitary conditions where it may be contaminated with microbial organisms or any substance that renders the product harmful to the consumer.
- It is packaged in a container that is composed of poisonous or harmful substances that renders the product harmful to the user.
- It’s not a hair dye but contains an unsafe color additive as determined by the FD&C Act. (Section 721(a) of the FD&C Act [21 U.S.C. 379(a)]
In short, the FD&C Act addresses multiple aspects of skincare product safety including the composition of the product, the manufacturing, shipping and storing conditions of the product, the container. An exception for coal-tar hair dyes.
What is a misbranded product?
The FD&C Act defines a misbranded product as one that…
- contains misleading or false information on the label.
- does not contain the name and place of the business of the manufacturer, packer or distributor on the label, the quantity of contents in terms of weight or measure.
- does not contain any prominently displayed required information in an easy to read and understood fashion by an ordinary individual under customary conditions of use.
- is packaged in a misleading container.
- is a color additive and does not fulfill the packaging and labeling requirements of such color additives.
- has packaging and labeling in violation of the Poison Prevention Packaging Act of 1970.
The FD&C Act assures the presence of appropriate information on cosmetic packaging. It also assures that the information is not misleading.
The information must be readable and the packaging is not misleading. It assures the proper packaging and labeling of color additives and addresses the need for special packaging if needed as defined in the Poison Prevention Packaging Act.
Enforcement of violations of the FD&C Act
The FDA has the right to enforce any of these regulations.
Inspectors can inspect skincare product manufacturing plants or offices without prior notice. If deemed necessary, inspections can occur on a routine basis. The FDA has the authority to:
- Restrict or ban cosmetic ingredient usage for safety reasons.
- Collect samples of cosmetic ingredients or finished products.
- Mandate warning labels on cosmetic products.
- Issue warning letters to manufacturers, packagers or distributors.
- Seize illegal products.
- Stop unlawful activities.
- Prosecute violators of these laws.
- Collaborate with companies to implement product recalls.
The Voluntary Cosmetic Reporting Program
The FDA has a Voluntary Cosmetic Reporting Program (VCRP) where manufacturers, packers, and distributors of cosmetic products are encouraged to do the following:
- Register their manufacturing sites
- Register their products and ingredients
- Report any adverse reactions or consumer comments.
This information is used to help the FDA regulate cosmetics marketing in the U.S. It also assists the industry-funded Cosmetic Ingredient Review (CIR), an independent panel of scientific experts, in assessing the safety of ingredients. The results of these safety evaluations are published in the International Journal of Toxicology, a peer-reviewed scientific journal.
It is common to hear critics complain that the U.S. system is not strict enough, that the European Union has much stricter laws and safety regulations regarding cosmetics. In actuality, this is not true. The two systems are very similar.
The FDA has prohibited the use of approximately 12 cosmetic ingredients. An additional 11 ingredients have been deemed not safe for use in cosmetics by the CIR.
The European Union has banned many more ingredients, almost 1400 to be exact. But 80% of those ingredients have never been and would never be used in cosmetics.
And the few on the EU list that are used in the United States have been reviewed by scientific experts who have found that these ingredients can be safely used in cosmetics when used in recommended and often limited doses.
How safe is the cosmetic industry?
Let’s compare the safety of the auto industry, the food industry, and the skincare industry.
According to the National Safety Council, in 2017, there were over 40,000 motor vehicle fatalities. The National Highway Traffic Safety Administration reports 1,889,000 injuries due to car accidents the same year.
The Centers for Disease Control and Prevention (CDC) estimates that approximately 48 million Americans get sick from food poisoning annually. They estimate that 128,000 Americans require hospitalization and 3,000 people die of foodborne disease each year in the United States.
When used as recommended, reactions to topical skincare products are few. Between 2004-2016, 5,144 adverse reactions, less than 400 per year, were reported to the FDA.
The average woman uses approximately 16 different products a day. Each product contains 20 – 30 ingredients. Therefore, she exposes herself to hundreds of chemical compounds daily. Yet, skin reactions remain uncommon.
The bottom line
My intention is neither to belittle skincare product reactions nor to deny that they exist. Rather it is to put the safety of the industry in perspective. Although the FDA does not “approve” cosmetics, the FDA absolutely regulates the cosmetic industry.
I ardently support more scientific evaluation of cosmetic compounds. And, I encourage manufacturers and the research community to find safe and effective ingredients for use in cosmetic formulation. But, my dear readers, don’t let fear-mongering panic you. Instead, just enjoy your favorite cosmetics.
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